Retractable fluid collection device

ABSTRACT

Retractable medical device including a body having an open back end and a front end. A movable member is arranged within the body. The movable member has a back end and a front end. A needle holding member is movable to a retracted position within the movable member when the movable member experiences at least one of: the front end of the movable member is caused to expand generally radially; the back end of the movable member is caused to contract generally radially; the front end of the movable member is caused to expand generally radially when the back end of the movable member is caused to contract generally radially; and axial movement caused by a cap closing off the back end of the body which engages a tapered surface of the back end of the movable member.

CROSS-REFERENCE TO RELATED APPLICATIONS

The instant application is a continuation of U.S. non-provisionalapplication Ser. No. 11/738,240 filed on Apr. 20, 2007. The disclosureof this application is hereby expressly incorporated by reference heretoin its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to devices used to collect fluidsamples from patients. More specifically, this invention relates to adevice which utilizes a holder having a double-ended needle that can beretracted into the holder when a cap of the holder is closed. Theinvention also relates to a method of collecting a fluid sample with thedevice as well as a method of making the device. The invention alsorelates to a blood sample collection device that automatically retractsthe double-ended needle into the holder after a cap closes off the openend of the holder

2. Discussion of Background Information

Prevention of needle sticks is of paramount concern in the healthcareindustry because of serious and deadly risk factors associated with AIDSand other serious communicable diseases. Typical blood collectiondevices utilize a needle inserted into a patient's vein so as to drawblood through the needle into an associated separate collectionreservoir. Accidental needle sticks from previously used needles canoccur during the fluid withdrawing process and subsequent handling anddisposal operation. Until such used medical devices are destroyed, theyremain a risk to those handling them.

Devices used for blood sampling are well know and include a collectiondevice sold under the trademark Vacutainer® by Becton DickinsonCorporation. This device has a tubular syringe-like body with a needlein the front end, part of which extends back into a tubular syringe-likeshell. Part of the needle extends externally for punching the skin. Anevacuated collection tube with a rubber stopper is placed into the openback of the syringe-like shell with the rubber stopper against theinternal end of the needle. After the skin is punctured, the collectiontube is pushed forward to cause the needle to enter the evacuated tube.Vacuum helps draw blood into the collecting tube. When a sufficientsample has been obtained, the collecting tube and the stopper are simplywithdrawn from the tubular shell and sent to the laboratory. Thisparticular device has a permanently extended needle and an opening inthe back for the collection tube which remains open after the collectiontube is removed, leaving small quantities of blood and an internallyexposed needle.

Retractable medical devices which are used for collecting fluid samplesfrom patients are also known. An early example of such a device is U.S.Pat. No. 4,813,426 which employs a mechanically translatable insertholding a double-ended needle. This device has a position whichcompresses a spring portion of the holder. When buttons extending fromopposite sides of the outer tube are compressed, the needle carrier canbe mechanically moved to the position of us or to a rearward safeposition. U.S. Pat. No. 4,838,863 describes a spring loaded double endedneedle carrier in a T-shaped housing having an opening behind for thesample tube. The needle holder is locked in a use position with aremovable pin which is withdrawn to retract the needle. Alternately,breakable tabs on the needle holder extend laterally under a shelf withpins which may be pushed down when the sample tube is inserted tofracture the breakable tabs thereby releasing the needle holder which iswithdrawn into the interior as the sample tube is removed. Subsequently,a cap is provided to close the back. Allard does not explain how onecould assemble the device without making the outer body in two or morepieces.

Other devices attach the double ended needle to a partially withdrawableplunger with an opening in back for the sample tube. U.S. Pat. No.5,423,758 to shaw, the disclosure of which is hereby expresslyincorporated by reference in its entirety, utilizes a tubular outer bodywith a partially movable plunger. The plunger has a separable needleholding portion for a double ended needle and an opening in the back ofthe plunger for a sample tube. It utilizes a two position end cap fromwhich the sample tube extends. The plunger is used to position andretract the needle assembly. U.S. Pat. No. Re. 39,107 to shaw, thedisclosure of which is hereby expressly incorporated by reference in itsentirety, similarly utilizes a tubular outer body with a partiallymovable plunger. The plunger has a separable needle holding portion fora double ended needle and an opening in the back of the plunger for asample tube. It utilizes a two position end cap from which the sampletube extends. The plunger is used to position and retract the needleassembly.

The invention aims to improper devices of the type disclosed in U.S.Pat. Nos. 5,423,758 and Re. 39,107 to shaw by providing a releasablelocking connection between the plunger and the needle holding portionand/or by causing the connection between these two members to releasewhen the plunger experiences pivoting movement.

A conventional blood collection device of the type described above isshown in FIGS. 1-10 wherein the device 1 has an outer sleeve member 2which includes a proximal end 2 a which is configured to allow anexternal needle N of a double-ended needle member or holder 3 to passtherethrough and a distal end 2 b which can be closed off by a cap 5.The needle holder 3 has an outer circumferential surface OCS whichfrictionally engages with an inner circumferential surface ICS of aproximal end of an inner sleeve 4. The device 1 also includes a spring 6which functions to move the needle holder 3 when the outercircumferential surface OCS of the needle holder 3 no longerfrictionally engages with the inner circumferential surface ICS of theproximal end of the inner sleeve 4. As is shown from FIG. 4, it isbelieved that the device 1 functions as follows: once a user moves thecap 5 to the closed position, the sleeve 4 is caused to move axially inthe proximal direction, which, in turn, causes the outer circumferentialsurface OCS of the needle holder 3 to disengage from the innercircumferential surface ICS of the proximal end of the inner sleeve 4.The spring 6 is then free to move the needle holder 3 within the sleeve4 in a distal direction which ensures that the needle holder 3 is fullyand safely arranged within the device 1. The device 1 can then be safelyhandled and discarded.

SUMMARY OF THE INVENTION

According to one non-limiting aspect of the invention there is provideda retractable medical device comprising a body having an open back endand a front end, a movable member arranged within the body, the movablemember having a back end and a front end, a needle holding memberarranged in an area of the front end of the movable member, and a springstructured and arranged to move the needle holding member to a retractedposition within the movable member when the movable member experiencesat least one of: the front end of the movable member is caused to expandgenerally radially; the back end of the movable member is caused tocontract generally radially; the front end of the movable member iscaused to expand generally radially when the back end of the movablemember is caused to contract generally radially; and axial movementcaused by a cap closing off the back end of the body which engages atapered surface of the back end of the movable member.

The body and the movable members can be at least one of generallycylindrical and generally tubular. The movable member may be sized andconfigured to at least partially receive therein one of a fluidcollection tube and an evacuated blood collection receptacle. An outerperipheral surface of the needle holding member may frictionally engagewith an inner surface of the front end of the movable member. An outerperipheral surface of the needle holding member may comprise at leastone projection which engages with at least one recess arranged on aninner surface of the front end of the movable member. An outerperipheral surface of the needle holding member may comprise at leastone recess which engages with at least one projection arranged on aninner surface of the front end of the movable member. The body maycomprise a device arranged within the body for limiting axial movementof the movable member within the body.

The device may further comprise a cap structure and arranged to closeoff a back end of the body. The device may further comprise a capconnected by a living hinge to the body. The device may further comprisea cap having a portion which contacts the back end of the movablemember. The device may further comprise a cap having tapered surfaceswhich contact tapered surfaces of the back end of the movable member.The device may further comprise a cap structured and arranged to lock tothe back end of the body. The device may further comprise a capstructured and arranged to cause the needle holding member to move tothe retracted position by the spring when the cap is locked to the body.The device may further comprise a cap structured and arranged to causethe needle holding member to move to the retracted position by thespring when the cap closes off the back end of the body. The device mayfurther comprise a cap structured and arranged to cause the needleholding member to move to the retracted position by the spring when thecap engages with a back end of the movable member.

The movable member may comprise an internal surface which limitsretraction movement of the needle holding member. The movable member maycomprise an internal annular surface which limits retraction movement ofthe needle holding member. The needle holder may be structured andarranged to support a double-ended needle. The needle holder may bestructured and arranged to retain a removable double-ended needle.

The device may further comprise a cap having an outer rim larger than anopening in the back of the body and an inner rim comprising at least oneprotrusion structured and arranged to engage with the back end of themovable member. The device may further comprise a cap having an outerrim larger than an opening in the back of the body and at least twooppositely arranged protrusions structured and arranged to engage withthe back end of the movable member. The device may further comprise acap having an outer rim larger than an opening in the back of the bodyand at least two oppositely arranged tapered protrusions structured andarranged to engage with tapered surfaces of the back end of the movablemember.

The movable member may comprise oppositely arranged elongated slotsextending to the front end of the movable member, whereby a width of theelongated slots changes when the needle holding member is caused to moveto the retracted position. The movable member may comprise oppositelyarranged elongated slots extending to the back end of the movablemember, whereby a width of the elongated slots changes when the needleholding member is caused to move to the retracted position. The movablemember may comprise oppositely arranged first elongated slots extendingto the front end of the movable member and oppositely arranged secondelongated slots extending to the back end of the movable member, wherebya width of the elongated first and second slots changes when the needleholding member is caused to move to the retracted position. The movablemember may comprise first elongated slots extending to the front end ofthe movable member and second elongated slots extending to the back endof the movable member, whereby a width of the elongated first and secondslots changes when the needle holding member is caused to move to theretracted position. The movable member comprises first elongated slotsextending to the front end of the movable member, second elongated slotsextending to the back end of the movable member, and a connectingportion disposed between the first and second elongated slots, whereby awidth of the elongated first and second slots changes when the needleholding member is caused to move to the retracted position. The movablemember may comprise two-semi-cylindrical members which, when arranged toform a cylindrical member, form first elongated slots extending to thefront end of the movable member, second elongated slots extending to theback end of the movable member, and a connecting portion disposedbetween the first and second elongated slots, whereby a width of theelongated first and second slots changes when the needle holding memberis caused to move to the retracted position. The movable member maycomprise at least one elongated slot extending to the front end of themovable member and a tapered surface arranged at the front end of themovable member which is structured and arranged to engage a taperedsurface inside the body to thereby cause the needle holding member tomove to the retracted position. The movable member may comprise at leasttwo oppositely arranged slots extending to the front end of the movablemember and a tapered surface arranged at the front end of the movablemember which is structured and arranged to engage a tapered surfaceinside the body to thereby cause the needle holding member to move tothe retracted position. The movable member may comprise at least oneslot extending to the front end of the movable member and the bodycomprises at least one projection having tapered surfaces which arestructured and arranged to engage the at least one slot to thereby causethe needle holding member to move to the retracted position. The movablemember may comprise at least one slot arranged on the front end of themovable member and the body comprises at least one projection havingtapered surfaces, and wherein the slot engages with the taperedsurfaces, a width of the at least one slot changes to thereby cause theneedle holding member to move to the retracted position. The movablemember may comprise at least two oppositely arranged slots arranged onthe front end of the movable member and the body comprises at least twooppositely arranged projections each having tapered surfaces, andwherein each slot engages with each set of the tapered surfaces, a widthof each slot changes to thereby cause radial expansion of the front endof the movable member. The movable member may comprise at least one slotextending to the front end of the movable member and the body comprisesat least one projection arranged in an inner cylindrical surface of thebody between the front end and the back end of the body, and wherein theat least one slot comprises tapered surfaces structured and arranged toengage with the at least one projection, whereby a width of the at leastone slot changes when the movable member moves axially within the bodyand when the tapered surfaces engage with the at least one projection.The body may comprise at least one projection arranged in an innercylindrical surface of the body between the front end and the back endof the body and wherein the at least one projection is structured andarranged to serve as an axle which allows portions of the movable memberto pivot about the axle. The body may comprise oppositely arrangedprojections arranged in an inner cylindrical surface of the body betweenthe front end and the back end of the body and wherein each projectionis structured and arranged to serve as an axle which allows portions ofthe movable member to pivot about the axle.

The invention also provides for a retractable medical device comprisinga tubular body having an open back end and a front end, a movable sleevearranged within the body, the movable sleeve having a back end and afront end, the movable sleeve being sized and configured to at leastpartially receive therein one of a fluid collection tube and anevacuated blood collection receptacle, a needle holding membercomprising a centrally disposed opening for receiving a double-endedneedle and being axially retained in an area of the front end of themovable sleeve, a spring structured and arranged to move the needleholding member to a retracted position within the movable sleeve, and acap structured and arranged to close-off the back end of the tubularbody, wherein, when the cap is positioned to close-off the back end ofthe tubular body, at least one of: the movable sleeve experiences axialmovement which participates in causing the front end of the movablesleeve to expand generally radially; the back end of the movable sleeveexperiences radial contraction which causes the front end of the movablesleeve to expand generally radially; and the back end of the movablesleeve experiences radial contraction which causes portions of the frontend of the movable sleeve to pivot open.

The invention also provides for a single-use blood sampling devicecomprising a tubular body having an open back end and a front end, asleeve arranged within the body, the sleeve having a back end and afront end, the sleeve being sized and configured to at least partiallyreceive therein one of a fluid collection tube and an evacuated bloodcollection receptacle, a needle holding member comprising a centrallydisposed opening for receiving a double-ended needle and being axiallyretained in an area of the front end of the sleeve, a spring structuredand arranged to move the needle holding member to a retracted positionwithin the sleeve, and a cap structured and arranged to close-off theback end of the tubular body, wherein, when the cap is positioned toclose-off the back end of the body, the needle holding member isautomatically caused to move to the retracted position within the sleeveas a result of at least one of: the sleeve experiencing axial movementwhich participates in causing the front end of the sleeve to expandgenerally radially; the back end of the sleeve experiencing radialcontraction which causes the front end of the sleeve to expand generallyradially; and the back end of the sleeve experiencing radial contractionwhich causes portions of the front end of the sleeve to pivot open.

The invention also provides for a method of taking a fluid sample usingthe device of the type described above, wherein the method comprisesinserting a receptacle into the device, removing the receptacle from thedevice, and placing a cap onto the back end of the body to thereby causethe needle holding member to move to the retracted position.

Other exemplary embodiments and advantages of the present invention maybe ascertained by reviewing the present disclosure and the accompanyingdrawing.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detailed descriptionwhich follows, in reference to the noted plurality of drawings by way ofnon-limiting examples of exemplary embodiments of the present invention,in which like reference numerals represent similar parts throughout theseveral views of the drawings, and wherein:

FIG. 1 shows a cross-section view of a type of prior art bloodcollection device. The device is shown in a prior-use or packagedposition and is ready to receive therein a collection tube;

FIG. 2 shows an enlarged cross-section view of a portion of FIG. 1;

FIG. 3 shows an enlarged cross-section view of FIG. 2 after the cap ismoved to the closed position thereby causing the needle holding memberto move towards the retracted position;

FIG. 4 shows a cross-section view of FIG. 1 after the cap is moved tothe closed position and after the needle holding member is moved to thefully retracted position. The device can now be safely disposed of andhandled because the double-ended needle which is mounted to the needleholding member if fully contained within the device and a user thereforecannot be accidentally pricked by the needle;

FIG. 5 shows a rear end view of FIG. 4;

FIG. 6 shows a top cross-section view of the tubular outer body used inthe embodiment shown in FIG. 1;

FIG. 7 shows a cross-section view of the needle holding member used inthe embodiment shown in FIG. 1;

FIG. 8 shows a cross-section view of the needle holding member and aconventional type double-ended needle mounted thereto and used in theembodiment shown in FIG. 1;

FIG. 9 shows a cross-section view of the movable member used in theembodiment shown in FIG. 1;

FIG. 10 shows a cross-section view of the movable member and theassembly shown in FIG. 8 mounted thereto and used in the embodimentshown in FIG. 1;

FIG. 11 shows a cross-section view of a blood collection deviceaccording to one embodiment of the invention. The device is shown in aprior-use or packaged position and is ready to receive therein acollection tube;

FIG. 12 shows a cross-section view of FIG. 11 after the cap is moved tothe closed position and before the needle holding member is moved to thefully retracted position. This figure illustrates how the front of themovable member is cause to expand generally radially (thereby releasingits engagement with the needle holding member) by a radially contractingthe rear end of the movable member with the aid of the cap;

FIG. 13 shows a cross-section view of FIG. 11 after the cap is moved tothe closed position and after the needle holding member is moved to thefully retracted position. The device can now be safely disposed of andhandled because the double-ended needle which is mounted to the needleholding member if fully contained within the device and a user thereforecannot be accidentally pricked by the needle;

FIG. 14 shows a cross-section view of the movable member and theassembly shown in FIG. 15 mounted thereto and used in the embodimentshown in FIG. 11;

FIG. 15 shows a cross-section view of the needle holding member and aconventional type double-ended needle mounted thereto and used in theembodiment shown in FIG. 11;

FIG. 16 shows a side view of another embodiment of a needle holdingmember with a conventional type double-ended needle mounted thereto andwhich can be used in the embodiment shown in FIG. 11;

FIG. 17 shows a side view of still another embodiment of a needleholding member with a conventional type double-ended needle mountedthereto and which can be used in the embodiment shown in FIG. 11;

FIG. 18 shows a cross-section view of the movable member used in theembodiment shown in FIG. 11;

FIG. 19 shows a side view of FIG. 18;

FIG. 20 shows a side cross-section view of the tubular outer body usedin the embodiment shown in FIG. 11;

FIG. 21 shows an enlarged top cross-section view of a portion of thetubular outer body used in the embodiment shown in FIG. 1;

FIG. 22 shows a cross-section view of another embodiment of the bloodcollection device. The device is identical to that of FIG. 11 exceptthat the movable member utilizes spaced apart projections and the needleholding member utilizes a circumferential recess. FIG. 22 also showswhat happens after the cap is moved to the closed position, i.e., thefront of the movable member is cause to expand generally radially(thereby releasing its engagement with the needle holding member) by aradially contracting the rear end of the movable member with the aid ofthe cap;

FIG. 23 shows a side cross-section view of another embodiment of amovable member which can be used in the embodiment shown in FIG. 11;

FIG. 24 shows a side cross-section view of still another embodiment of amovable member which can be used in the embodiment shown in FIG. 11;

FIG. 25 shows a cross-section view of still another embodiment of theblood collection device. The device utilizes an axially movable ringwhich, when moved distally, allows the front or proximal end of themovable member to expand radially when the movable member moves relativeto the needle holding member. This would occur when the cap is moved tothe closed position;

FIG. 26 shows a cross-section view of the movable member and theassembly shown in FIG. 27 mounted thereto and used in the embodimentshown in FIG. 25;

FIG. 27 shows a side cross-section view of the needle holding memberwith a conventional type double-ended needle mounted thereto and whichis used in the embodiment shown in FIG. 25;

FIG. 28 shows a side cross-section view of the movable member which isused in the embodiment shown in FIG. 25;

FIG. 29 shows a side cross-section view of the ring which is used in theembodiment shown in FIG. 25;

FIG. 30 shows an enlarged cross-section view of a portion of FIG. 25 andafter the ring is caused to move distally and after the movable memberis caused to release from engagement with the needle holding member;

FIG. 31 shows a cross-section view of still another embodiment of theblood collection device. The device utilizes an annular outwardlytapered projection on an inside surface of the outer body which engageswith an inwardly tapered leading end of the movable member to cause thefront or proximal end of the movable member to expand radially when themovable member moves relative to the needle holding member. This wouldoccur when the cap is moved to the closed position;

FIG. 32 shows an enlarged cross-section view of a portion of FIG. 31 andbefore the movable member is caused to release from engagement with theneedle holding member;

FIG. 33 shows an enlarged cross-section view of a proximal end of thesleeve used in the embodiment shown in FIG. 31;

FIG. 34 shows a cross-section view of still another embodiment of theblood collection device. The device utilizes an annular outwardlytapered projection on an inside surface of the outer body which engageswith an inwardly tapered leading end of the movable member to cause thefront or proximal end of the movable member to expand radially when themovable member moves relative to the needle holding member. This wouldoccur when the cap is moved to the closed position;

FIG. 35 shows an enlarged partial cross-section view of still anotherembodiment of the blood collection device. The device utilizes anannular outwardly tapered projection on an inside surface of the outerbody which engages with an inwardly tapered leading end of the movablemember to cause the front or proximal end of the movable member toexpand radially when the movable member moves relative to the needleholding member. This would occur when the cap is moved to the closedposition;

FIG. 36 shows the embodiment of FIG. 35 after the front or proximal endof the movable member is cause to expand radially when the movablemember moves relative to the needle holding member and before the needleholding member moves to the retracted position. This would occur whenthe cap is moved to the closed position;

FIG. 37 shows an enlarged partial cross-section view of still anotherembodiment of the blood collection device. The device utilizes one ormore tapered projections on an inside surface of the outer body whichengages with one or more slots in the leading end of the movable memberto cause the front or proximal end of the movable member to expandradially when the movable member moves relative to the needle holdingmember. This would occur when the cap is moved to the closed position;

FIG. 38 shows an enlarged cross-section view of a portion of FIG. 37rotated 90 degrees;

FIG. 39 shows an enlarged cross-section view of another embodiment. Thisembodiment is similar to that of FIG. 37 except that it utilizes fourproximal slots and four proximal slot expanding projections arranged inthe body. The figure shows the device after the movable member or sleeveis caused to release from engagement with the needle holding member;

FIG. 40 shows a side cross-section view of still another embodiment ofthe blood collection device. The device utilizes one or more circularprojections on an inside surface of the outer body which engages withone or more tapered slots in the movable member to cause the front orproximal end of the movable member to expand radially when the movablemember moves relative to the needle holding member. This would occurwhen the cap is moved to the closed position;

FIG. 41 shows an enlarged top cross-section view of a portion of thetubular outer body and the movable member used in the embodiment shownin FIG. 40; and

FIG. 42 shows a side cross-section view of still another embodiment ofthe blood collection device. The device utilizes one or more circularprojections on an inside surface of the outer body which engages withone or more tapered slots in the movable member to cause the front orproximal end of the movable member to expand radially when the movablemember moves relative to the needle holding member. This would occurwhen the cap is moved to the closed position.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings and first to FIGS. 11-21 which shows afirst non-limiting embodiment of a blood collection device 10 accordingto the invention. The device 10 includes a generally cylindrical outersleeve or outer body member 20 which includes a proximal end 20 aconfigured to allow an external needle N of a double-ended needle memberor holder 30 to pass therethrough, and a distal end 20 b which can beclosed off by a cap 50. An inner flange IF is arranged at the proximalend 20 a. The needle holder 30 has an outer circumferential surface OCS(see FIG. 15) which frictionally engages with an inner circumferentialsurface ICS (see FIGS. 13 and 18) of a proximal end of an inner sleeve40. The surfaces ICS and OCS have generally corresponding shapes andneed not be straight or cylindrical, i.e., they can also be, e.g.,tapered or have an other non-straight shapes. The device 10 alsoincludes a spring 60 which functions to move the needle holder 30distally when the outer circumferential surface OCS of the needle holder30 is released from frictional engagement with the inner circumferentialsurface ICS of the proximal end of the inner sleeve 40. As is evidentfrom FIG. 12, once a user moves the cap 50 to the closed position, thesleeve 40 is caused to move axially in the proximal direction which, inturn, causes outer circumferential surface OCS of the needle holder 30no longer frictionally engage with the inner circumferential surface ICSof the proximal end of the inner sleeve 40. The spring 60 is then freeto move the needle holder 30 within the sleeve 40 in a distal directionwhich ensures that the needle holder 30 is fully and safely arrangedwithin the device 10. The device can then be safely handled anddiscarded.

The disengagement of the proximal end of the sleeve 40 from the needleholder 30 (see FIG. 12) functions as follows. The sleeve 40 is preventedfrom moving axially backwards within the body 20 by two oppositelyarranged projections P, but is biased towards this direction by thespring 60 which FIG. 11 is substantially fully compressed. Theprojections P also function as static pivot points and allow thegenerally half-circular or arc-shaped sections 40 a and 40 b of thesleeve 40 to pivot relative each other. Thus, as shown in FIG. 12, whenthe distal ends of the generally half-circular or arc-shaped sections 40a and 40 b of the sleeve 40 are moved towards each other, the proximalends of the generally half-circular or arc-shaped sections 40 a and 40 bof the sleeve 40 are moved away from each other. As a result, the twooppositely arranged proximal slots PS widen while the two oppositelyarranged distal slots DS narrow. As is shown in FIG. 12, this pivotmovement is caused when the user moves the cap 50 to the closedposition, and more specifically, when the inner tapered surfaces TPE ofthe cap 50 engage with tapered surfaces TDE of the sleeve 40 and forcethe tapered surfaces TDE of the sleeve 40 inwardly.

With reference to FIGS. 11 and 12, when the user moves the cap 50 to theclosed position, the inner tapered surfaces TPE of the cap 50 engagewith tapered surfaces TDE of the sleeve 40 and force the taperedsurfaces TDE of the sleeve 40 inwardly. This, however, also causes thesleeve 40 to move a small amount in the distal direction, and thismovement is not prevented by the projections P. Instead, this movementis limited by the biasing force of the spring 60 and by contact betweena front-facing surface of the holder 30 and a rear-facing surface of theinner flange IF of the body 20.

As is shown in FIG. 13, when the user moves the cap 50 to the closedposition shown in FIG. 12, the pivoting movement of the sections 40 aand 40 b automatically causes the surface ICS to separate from thesurface OCS. Since the frictional engagement between the surface ICS andthe surface OCS constitutes the only engagement or connection betweenthe holder 30 and the sleeve 40, the disengagement of these surfacesleaves the holder 30 free to move axially distally. Furthermore, becausethe spring 60 maintains a biasing force against the holder 30, when theengagement is released, the spring 60 will automatically expand axiallyand force the holder 30 to move distally within the sleeve 40. Thus, inturn, results in the needle N being retracted into the sleeve 40 andpositions it safely within the body 20. The device 10 shown in FIG. 13is now rendered unusable, i.e., cannot be reused, and can be safelyhandled and disposed of without fear of the needle causing injury topersons who handle the used device 10.

With reference to FIGS. 14-19, it can be seen that the sleeve 40 and theneedle holder 30 constitute a sub-assembly with the generallyhalf-circular or arc-shaped sections 40 a and 40 b of the sleeve 40assuming a generally cylindrical shape. The two oppositely arrangedconnecting portions CP function as the only mechanism connectingtogether the arc-shaped sections 40 a and 40 b of the sleeve 40. Assuch, when the distal ends of these members 40 a and 40 b are movedtowards each other, the connecting portions CP become deflected and/orslightly elastically deformed thereby allowing the proximal ends of thegenerally half-circular or arc-shaped sections 40 a and 40 b of thesleeve 40 to move away from each other. However, in the relaxed shown inFIG. 14, the connecting portions CP ensure that the surfaces OSC and ICSremain in engagement. In order to assemble the sub-assembly shown inFIG. 14, one need only move the tapered surfaces TDE of the members 40 aand 40 b towards each other to cause a widening of the slots PS (andsimultaneously a narrowing of the slot DS), insert the holder 30 withinthe proximal end of the sleeve 40, and then remove the force applied tothe surfaces TDE allowing the sleeve 40 to again assume a generallycylindrical shape shown in FIG. 14. Of course, proper insertion andconnection of the holder 30 requires ensuring that the projections CPP,EPP (see FIGS. 16 and 17) are aligned with the circumferential groove Gof the sleeve 40 (see FIG. 18).

The sub-assembly shown in FIG. 14 can be slid into the distal end of thebody 20 in a relatively easy manner because the two integrally formedoppositely arranged projections P have a tapered inward facing surfacewhich allows the connecting portions CP to slide over the projections P.The projections P also serve to align and/or guide the proper insertionmovement of the sub-assembly shown in FIG. 14 as follows. Upon insertionof the sleeve 40 into the distal end of body 20, the user will align theproximal slots PS of the sleeve 40 with the projections P and then movethe sleeve 40 axially in the proximal direction. Once the connectingportions CP of the sleeve 40 reach the projections P, the taperedsurfaces of the projections P allow these portions CP to pass over theprojections P until they pass the projections P and snap outwardly andassume the final position shown in FIG. 11. At this point, therear-facing surface of the portions CP will abut the forward facingsurface CSS (see FIG. 21) of the projections P. The spring 60 can, ofcourse, be installed inside the body 20 in the same way as, e.g., theprior art device shown in FIGS. 1-10, and is preferably installed in thebody 20 prior to or simultaneously with the insertion of thesub-assembly shown in FIG. 14.

With reference to FIGS. 16-17, it can be seen that the needle holder 30constitutes a sub-assembly having, in the case of FIG. 16, four equallyangularly spaced circular projections CPP which are sized to engage orextend into the groove G of the sleeve 40. Of course, the invention alsocontemplates using as few as two oppositely arranged projections CPP.Furthermore, the projections CPP need not be circular and/or rounded andcan be any shape (e.g., square, triangular, oval, polygonal, etc.) whichsecurely and releasably engages with the groove G. Furthermore, thegroove G need not correspond in shape to that of the projections CPP,and can similarly have any shape which securely and releasably engageswith the projections CPP. By way of non-limiting example FIG. 17 showsfour equally angularly spaced elongated projections EPP which are sizedto engage or extend into the groove G of the sleeve 40. Again, theinvention also contemplates using as few as two oppositely arrangedprojections EPP. Furthermore, the projections EPP need not be roundedand can be any shape (e.g., square, triangular, oval, polygonal, etc.)which securely and releasably engages with the groove G. The inventionalso contemplates other mechanisms for providing a releasable engagementbetween the surfaces OCS and ICS. Still further, instead of merelyutilizing a single groove G and a single set of projections CPP, EPP,the invention also contemplates using two or more axially spaced groovesG and two or more axially spaced sets of projections CPP, EPP.

FIG. 22 shows a second non-limiting embodiment of a blood collectiondevice 10′ according to the invention. The device 10′ is shown in theused or post use position. As was the case in the previous embodiment,the device 10′ includes a generally cylindrical outer sleeve or outerbody member 20 which includes a proximal end 20 a configured to allow anexternal needle N of a double-ended needle member or holder 30″ to passtherethrough, and a distal end 20 b which can be closed off by a cap 50.An inner flange IF is arranged at the proximal end 20 a. The needleholder 30″ has an outer circumferential surface OCS which frictionallyengages with an inner circumferential surface ICS of a proximal end ofan inner sleeve 40′. The surfaces ICS and OCS have generallycorresponding shapes and need not be straight or cylindrical, i.e., theycan also be, e.g., tapered or have an other non-straight shapes. Thedevice 10′ also includes a spring 60 which functions to move the needleholder 30″ distally when the outer circumferential surface OCS of theneedle holder 30″ is released from frictional engagement with the innercircumferential surface ICS of the proximal end of the inner sleeve 40′.As was the case in the previous embodiment, once a user moves the cap 50to the closed position, the sleeve 40′ is caused to move axially in theproximal direction which, in turn, causes outer circumferential surfaceOCS of the needle holder 30″ no longer frictionally engage with theinner circumferential surface ICS of the proximal end of the innersleeve 40′. The spring 60 is then free to move the needle holder 30″within the sleeve 40′ in a distal direction which ensures that theneedle holder 30″ is fully and safely arranged within the device 10′.This is shown in FIG. 22. The device can then be safely handled anddiscarded.

The disengagement of the proximal end of the sleeve 40′ from the needleholder 30″ functions as follows. The sleeve 40′ is prevented from movingaxially backwards within the body 20 by two oppositely arrangedprojections P (not shown, but similar to the previous embodiment), butis biased towards this direction by the spring 60. As in the previousembodiment, the projections P also function as static pivot points andallow the generally half-circular or arc-shaped sections 40′a and 40′bof the sleeve 40′ to pivot relative each other. Thus, as shown in FIG.22, when the distal ends of the generally half-circular or arc-shapedsections 40′a and 40′b of the sleeve 40′ are moved towards each other,the proximal ends of the generally half-circular or arc-shaped sections40′a and 40′b of the sleeve 40′ are moved away from each other. As aresult, the two oppositely arranged proximal slots PS widen while thetwo oppositely arranged distal slots DS narrow. As is shown in FIG. 22,this pivot movement is caused when the user moves the cap 50 to theclosed position, and more specifically, when the inner tapered surfacesTPE of the cap 50 engage with tapered surfaces TDE of the sleeve 40′ andforce the tapered surfaces TDE of the sleeve 40′ inwardly.

As is evident from FIG. 22, when the user moves the cap 50 to the closedposition shown in FIG. 22, the pivoting movement of the sections 40′aand 40′b automatically causes the surface ICS to separate from thesurface OCS. Since the frictional engagement between the surface ICS andthe surface OCS constitutes the only engagement or connection betweenthe holder 30″ and the sleeve 40′, the disengagement of the surfaces ICSand OCS leaves the holder 30″ free to move axially in the distaldirection. Furthermore, because the spring 60 maintains a biasing forceagainst the holder 30″, when the engagement is released, the spring 60will automatically expand axially and force the holder 30″ to movedistally within the sleeve 40′. Thus, in turn, results in the needle Nbeing retracted into the sleeve 40′ and positions it safely within thebody 20. The device 10′ shown in FIG. 22 is now rendered unusable, i.e.,cannot be reused, and can be safely handled and disposed of without fearof the needle causing injury to persons who handle the used device 10′.

In the embodiment shown in FIG. 22, the needle holder 30″ has twoequally angularly spaced circular indentations or blind recesses CRRwhich are sized to receive therein and engage with correspondingprojections CPR of the sleeve 40′. Of course, the invention alsocontemplates using more than two oppositely arranged projections CPR andrecesses CRR. Additionally, it is possible, and even preferable from amanufacturing or assembly standpoint, to utilize a continuous orcircumferential groove in place of the two recesses CRR. Furthermore,the projections CPR need not be circular and/or rounded and can be anyshape (e.g., square, triangular, oval, polygonal, etc.) which securelyand releasably engages with the recesses CRR. Furthermore, the recessCRR need not correspond in shape to that of the projections CPR, and cansimilarly have any shape which securely and releasably engages with theprojections CPR. Other than the different configurations shown in FIG.22 regarding the surfaces ICS and OCS, the embodiment shown in FIG. 22is substantially similar to that of FIGS. 11-21.

FIG. 23 shows another embodiment of an inner sleeve 40″ which can beused, e.g., in the embodiment of FIGS. 11-21 in place of the sleeve 40.The sleeve 40″ is similar to sleeve 40 except that the connectingportions CP′ in the instant embodiment is formed by a sidewaysdisconnectable joint formed by circular projection BP and a socketrecess SR which forms a pivot bearing for the projection BP. Theadvantage of this joint CP′ system is that it allows arc-shaped members40″a and 40″b forming the sleeve 40″ to pivot relative to each othermore easily, i.e., when the cap 50 is moved to the closed position andthe tapered surfaces TPE engage the tapered surfaces TDE. Anotheradvantage is that the arc-shaped members 40″a and 40″b forming thesleeve 40″ can be formed separately and allows the sleeve 40″ and theholder 30 to be assembled more easily.

FIG. 24 shows another embodiment of an inner sleeve 40″ which can beused, e.g., in the embodiment of FIGS. 11-21 in place of the sleeve 40.The sleeve 40′″ is similar to sleeve 40 except that the connectingportions CP″ in the instant embodiment is formed by a joint formed bycircular projection BP′ and a socket recess SR′ which forms a pivotbearing for the projection BP′. The circular projection BP′ and thesocket recess SR′ are connected to each other via a small connectingband which forms a living hinge LH. The advantage of this joint CP″system is that it allows arc-shaped members 40′″a and 40′″b forming thesleeve 40′″ to pivot relative to each other more easily, i.e., when thecap 50 is moved to the closed position and the tapered surfaces TPEengage the tapered surfaces TDE. As was the case in the embodiment ofFIG. 11, the sleeve 40″ is a one-piece member with arc-shaped members40″a and 40′″b connected to each other via the two living hinges LH.

FIGS. 25-29 show another non-limiting embodiment of a blood collectiondevice 100 according to the invention. The device 100 includes agenerally cylindrical outer sleeve or outer body member 200 whichincludes a proximal end 200 a configured to allow an external needle Nof a double-ended needle member or holder 300 to pass therethrough, anda distal end 200 b which can be closed off by a cap 500. An inner flangeIF is arranged at the proximal end 200 a. The needle holder 300 has anouter circumferential surface OCS (see FIG. 27) which frictionallyengages with an inner circumferential surface ICS (see FIG. 28) of aproximal end of an inner sleeve 400. The surfaces ICS and OCS havegenerally corresponding shapes and need not be straight or cylindrical,i.e., they can also be, e.g., tapered or have an other non-straightshapes. The device 100 also includes a spring 600 which functions tomove the needle holder 300 distally when the outer circumferentialsurface OCS of the needle holder 300 is released from frictionalengagement with the inner circumferential surface ICS of the proximalend of the inner sleeve 400. Once a user moves the cap 500 to the closedposition, the sleeve 400 is caused to move axially in the proximaldirection which, in turn, causes outer circumferential surface OCS ofthe needle holder 300 no longer frictionally engage with the innercircumferential surface ICS of the proximal end of the inner sleeve 400.The spring 600 is then free to move the needle holder 300 within thesleeve 400 in a distal direction which ensures that the needle holder300 is fully and safely arranged within the device 100. The device canthen be safely handled and discarded.

The disengagement of the proximal end of the sleeve 400 from the needleholder 300 functions as follows. The sleeve 400 is prevented from movingaxially backwards within the body 200 by a circumferential taperedshoulder TS engaging an inner tapered shoulder ITS of the body 200, butis biased towards this direction by the spring 600 which, in FIG. 25, issubstantially fully compressed. The sleeve 400 has a plurality ofproximal slots PS which divide the proximal end of the sleeve 400 into aplurality of spring fingers each having a portion of the surface ICS. Aring-shaped retaining sleeve RSS is movably mounted to the sleeve 400and is movable between the locked position shown in FIGS. 25 and 26, andan unlocked position characterized by movement of the ring RSS in thedistal direction or movement of the sleeve 400 in the proximal directionwhile the sleeve RSS remains static (similar to that shown in FIG. 30.When the sleeve 400 is moved in the proximal direction by the closing ofthe cap 500, the sleeve RSS contacts an annular surface the taperedshoulder ITS preventing the sleeve RSS from further movement in theproximal direction. The sleeve 400, however, continues to move in theproximal direction. When a point is reach where the sleeve RSS is movedsufficiently to the unlocked position, the spring fingers formed by theproximal slots PS are free to expand radially thereby releasing theengagement between the surface ICS of the sleeve 400 and the surface OCSof the holder 300. As a result, the proximal slots PS widen. Thismovement of the sleeve 400 and disengagement of the surfaces ICS and OCSis caused to occur automatically when the user moves the cap 500 to theclosed position, and more specifically, when an annular surface orproximal end of cap 500 contacts an annular surface or distal end of thesleeve 400 and forces the sleeve 400 to move axially in the proximaldirection.

Thus, when the user moves the cap 500 to the closed position (notshown), axial movement of the sleeve 400 and movement of the sleeve RSSrelative to the sleeve 400 automatically causes the surface ICS toseparate from the surface OCS. Since the frictional engagement betweenthe surface ICS and the surface OCS constitutes the only engagement orconnection between the holder 300 and the sleeve 400, the disengagementof these surfaces leaves the holder 300 free to move axially distally.Furthermore, because the spring 600 maintains a biasing force againstthe holder 300, when this engagement is released, the spring 600 willautomatically expand axially and force the holder 300 to move distallywithin the sleeve 400. This, in turn, results in the needle N beingretracted into the sleeve 400 and positions it safely within the body200. The device 100 is then rendered unusable, i.e., cannot be reused,and can be safely handled and disposed of without fear of the needlecausing injury to persons who handle the used device 100.

With reference to FIGS. 26-29, it can be seen that the sleeve 400, theretaining sleeve RSS, and the needle holder 300 constitute asub-assembly. The proximal end of the sleeve 400 forms a plurality ofarc-shaped sections or fingers divided by equally spaced slots PS. Assuch, these fingers are free to deflect outwardly or to slightlyelastically deformed outwardly. However, the sleeve RSS functions toprevent this movement and ensures that the fingers are pressed tightlyagainst the holder 300, and more specifically, that the surfaces OSC andICS remain in engagement until the sleeve RSS is moved to a positionwhich allows the fingers to deflect outwardly. In order to assemble thesub-assembly shown in FIG. 26, one need only slide the holder 300 intothe proximal end of the sleeve 400 and thereafter slide the sleeve RSSonto the distal end of the sleeve 400 and up to and over stopprojections arranged on the sleeve 400 as is shown in FIG. 26. Theholder 300 is then prevented from moving axially relative to the sleeve400 by virtue of engagement between the tapered circumferentialprojection TCP and the corresponding shaped recess in the surface ICS.

FIG. 30 shows another non-limiting embodiment of a blood collectiondevice 100′ according to the invention. The device 100′ includes agenerally cylindrical outer sleeve or outer body member 200′ whichincludes a proximal end 200′a configured to allow an external needle Nof a double-ended needle member or holder 300 to pass therethrough, anda distal end which can be closed off by a cap (not shown). An innerflange IF is arranged at the proximal end 200′a. The needle holder 300has an outer circumferential surface OCS which frictionally engages withan inner circumferential surface ICS of a proximal end of an innersleeve 400′. The surfaces ICS and OCS have generally correspondingshapes and need not be straight or cylindrical, i.e., they can also be,e.g., tapered or have an other non-straight shapes. The device 100′ alsoincludes a spring 600 which functions to move the needle holder 300distally when the outer circumferential surface OCS of the needle holder300 is released from frictional engagement with the innercircumferential surface ICS of the proximal end of the inner sleeve400′. Once a user moves the cap 500 to the closed position, the sleeve400′ is caused to move axially in the proximal direction which, in turn,causes outer circumferential surface OCS of the needle holder 300 nolonger frictionally engage with the inner circumferential surface ICS ofthe proximal end of the inner sleeve 400′. The spring 600 is then freeto move the needle holder 300 within the sleeve 400′ in a distaldirection which ensures that the needle holder 300 is fully and safelyarranged within the device 100. The device can then be safely handledand discarded.

The disengagement of the proximal end of the sleeve 400′ from the needleholder 300 functions as follows. The sleeve 400′ is prevented frommoving axially backwards within the body 200′ by a circumferentialtapered shoulder (similar to shoulder TS' of FIG. 31), but is biasedtowards this direction by the spring 600 which, in FIG. 30, is almostfully compressed. The sleeve 400′ has a plurality of proximal slots PSwhich divide the proximal end of the sleeve 400′ into a plurality ofspring fingers each having a portion of the surface ICS. A ring-shapedretaining sleeve RSS is movably mounted to the sleeve 400′ and ismovable between a locked position and the unlocked position shown inFIG. 30 which occurs upon movement of the ring RSS in the distaldirection or more accurately movement of the sleeve 400′ in the proximaldirection while the sleeve RSS remains static, i.e., prevented fromproximal movement by the shoulder ITS. When the sleeve 400′ is moved inthe proximal direction by the closing of the cap 500, the sleeve RSScontacts an annular surface the tapered shoulder ITS preventing thesleeve RSS from further movement in the proximal direction. The sleeve400′, however, continues to move in the proximal direction. When a pointis reach where the sleeve RSS is moved sufficiently to the unlockedposition (as is shown in FIG. 30), the spring fingers formed by theproximal slots PS are free to expand radially thereby releasing theengagement between the surface ICS of the sleeve 400′ and the surfaceOCS of the holder 300. As a result, the proximal slots PS widen. Thismovement of the sleeve 400′ and disengagement of the surfaces ICS andOCS is caused to occur automatically when the user moves the cap 500 tothe closed position, and more specifically, when an annular surface orproximal end of cap 500 contacts an annular surface or distal end of thesleeve 400′ and forces the sleeve 400′ to move axially in the proximaldirection.

Thus, when the user moves the cap 500 to the closed position (notshown), axial movement of the sleeve 400′ and movement of the sleeve RSSrelative to the sleeve 400′ automatically causes the surface ICS toseparate from the surface OCS. Since the frictional engagement betweenthe surface ICS and the surface OCS constitutes the only engagement orconnection between the holder 300 and the sleeve 400′, the disengagementof these surfaces leaves the holder 300 free to move axially distally.Furthermore, because the spring 600 maintains a biasing force againstthe holder 300, when this engagement is released, the spring 600 willautomatically expand axially and force the holder 300 to move distallywithin the sleeve 400′. This, in turn, results in the needle N beingretracted into the sleeve 400′ and positions it safely within the body200′. The device 100′ is then rendered unusable, i.e., cannot be reused,and can be safely handled and disposed of without fear of the needlecausing injury to persons who handle the used device 100′.

As was the case with the previous embodiment, the sleeve 400′, theretaining sleeve RSS, and the needle holder 300 constitute asub-assembly. The proximal end of the sleeve 400′ forms a plurality ofarc-shaped sections or fingers divided by equally spaced slots PS. Assuch, these fingers are free to deflect outwardly or to slightlyelastically deformed outwardly. However, the sleeve RSS functions toprevent this movement and ensures that the fingers are pressed tightlyagainst the holder 300, and more specifically, that the surfaces OSC andICS remain in engagement until the sleeve RSS is moved to a positionwhich allows the fingers to deflect outwardly. In order to assemble thissub-assembly, one need only slide the holder 300 into the proximal endof the sleeve 400′ and thereafter slide the sleeve RSS onto the distalend of the sleeve 400′ and up to and over stop projections arranged onthe sleeve 400′. The holder 300 is then prevented from moving axiallyrelative to the sleeve 400′ by virtue of engagement between the taperedcircumferential projection TCP and the corresponding shaped recess orgroove G in the surface ICS.

FIGS. 31-33 show another non-limiting embodiment of a blood collectiondevice 100″ according to the invention. The device 100″ includes agenerally cylindrical outer sleeve or outer body member 200″ whichincludes a proximal end 200″a configured to allow an external needle Nof a double-ended needle member or holder 30 to pass therethrough, and adistal end which can be closed off by a cap 500′. An inner flange IF isarranged at the proximal end 200″a. The needle holder 30 has an outercircumferential surface OCS which frictionally engages with an innercircumferential surface ICS of a proximal end of an inner sleeve 400″.The surfaces ICS and OCS have generally corresponding shapes and neednot be straight or cylindrical, i.e., they can also be, e.g., tapered orhave an other non-straight shapes. The device 100″ also includes aspring 600 which functions to move the needle holder 30 distally whenthe outer circumferential surface OCS of the needle holder 30 isreleased from frictional engagement with the inner circumferentialsurface ICS of the proximal end of the inner sleeve 400″. Once a usermoves the cap 500′ to the closed position, the sleeve 400″ is caused tomove axially in the proximal direction which, in turn, causes outercircumferential surface OCS of the needle holder 30 no longerfrictionally engage with the inner circumferential surface ICS of theproximal end of the inner sleeve 400″. The spring 600 is then free tomove the needle holder 30 within the sleeve 400″ in a distal directionwhich ensures that the needle holder 30 is fully and safely arrangedwithin the device 100″. The device can then be safely handled anddiscarded.

The disengagement of the proximal end of the sleeve 400″ from the needleholder 30 functions as follows. The sleeve 400″ is prevented from movingaxially backwards within the body 200″ by a circumferential taperedshoulder TS′, but is biased towards this direction by the spring 600which, in FIG. 31, is almost fully compressed. The sleeve 400″ has aplurality of proximal slots PS which divide the proximal end of thesleeve 400″ into a plurality of spring fingers each having a portion ofthe surface ICS. The proximal end of the spring fingers or the sleeve400″ includes a circumferential tapered portion TP1 which is configuredto engage with an annular or circumferential tapered portion TP2 of thebody 200″ when the sleeve 400″ is moved in the proximal direction by thecap 500′. Furthermore, when the sleeve 400″ is moved in the proximaldirection by the closing of the cap 500′, the tapered surfaces TP1 ofthe spring fingers of the sleeve 400″ contacts the tapered surface TP2and causes the spring fingers formed by the proximal slots PS to expandradially thereby releasing the engagement between the surface ICS of thesleeve 400″ and the surface OCS of the holder 30. As a result, theproximal slots PS widen. This movement of the sleeve 400″ anddisengagement of the surfaces ICS and OCS is caused to occurautomatically when the user moves the cap 500′ to the closed position,and more specifically, when an annular surface or proximal end of cap500′ contacts an annular surface or distal end of the sleeve 400″ andforces the sleeve 400″ to move axially in the proximal direction.

Thus, when the user moves the cap 500′ to the closed position (notshown), axial movement of the sleeve 400″ automatically causes thesurface ICS to separate from the surface OCS. Since the frictionalengagement between the surface ICS and the surface OCS constitutes theonly engagement or connection between the holder 30 and the sleeve 400″,the disengagement of these surfaces leaves the holder 30 free to moveaxially distally. Furthermore, because the spring 600 maintains abiasing force against the holder 30, when this engagement is released,the spring 600 will automatically expand axially and force the holder 30to move distally within the sleeve 400″. This, in turn, results in theneedle N being retracted into the sleeve 400″ and positions it safelywithin the body 200″. The device 100″ is then rendered unusable, i.e.,cannot be reused, and can be safely handled and disposed of without fearof the needle causing injury to persons who handle the used device 100″.

As was the case with some previous embodiments, the sleeve 400″ and theneedle holder 30 constitute a sub-assembly. The proximal end of thesleeve 400″ forms a plurality of arc-shaped sections or fingers dividedby equally spaced slots PS. The slots PS can be a few as two oppositelyarranged slots or as many as, e.g., 20 or more, with any whole numberbetween 2 and 20 being utilized. As such, these fingers are free todeflect outwardly or to slightly elastically deformed outwardly.However, the spring fingers include breakable and/or stretchableconnections BEC (see FIG. 33) which are designed to break or stretchwhen the spring fingers are caused to radially expand beyond a certainpoint, as occurs when the surface TP1 engages with the surface TP2.These integrally formed members BEC also ensure that the fingers arepressed tightly against the holder 30, and more specifically, that thesurfaces OSC and ICS remain in engagement until the surface TP1 engagessignificantly with the surface TP2 which allows the fingers to deflectoutwardly. In order to assemble this sub-assembly, one need only slidethe holder 30 into the proximal end of the sleeve 400″. The holder 30 isthen prevented from moving axially relative to the sleeve 400″ by virtueof engagement between the projections CPP (see FIG. 16) and thecorresponding shaped recess(s) or groove(s) in the surface ICS.

FIG. 34 show another non-limiting embodiment of a blood collectiondevice 100′″ according to the invention. The device 100′″ includes allof the features of the embodiment of FIGS. 31-33, except that the sleeve400′″ a stop slot opening SSO which receives therein a projection P ofthe type used in the embodiment shown in FIG. 11, instead of theshoulder TS′. The device 100′″ otherwise functions in the same way asthat of FIGS. 31-33.

FIGS. 35-36 show another non-limiting embodiment of a blood collectiondevice 100 ^(IV) according to the invention. The device 100 ^(IV)includes all of the features of the embodiment of FIGS. 31-33 or theembodiment of FIG. 34, except that the surface ICS utilizes a taperedgroove G and the surface OCS utilizes either a continuous taperedcircumferential projection which generally corresponds in shape to thegroove G or a plurality of tapered projections having the configurationshown. The device 100 ^(IV) otherwise functions in the same way as thatof FIGS. 31-33.

FIGS. 37 and 38 show another non-limiting embodiment of a bloodcollection device 100 ^(V) according to the invention. The device 100^(V) includes a generally cylindrical outer sleeve or outer body member200 ^(IV) which includes a proximal end 200 ^(IV) a configured to allowan external needle N of a double-ended needle member or holder 30 topass therethrough, and a distal end which can be closed off by a cap(not shown). An inner flange IF is arranged at the proximal end 200^(IV) a. The needle holder 30 has an outer circumferential surface OCSwhich frictionally engages with an inner circumferential surface ICS ofa proximal end of an inner sleeve 400 ^(IV). The sleeve 400 ^(V) canhave a configuration similar to that of FIG. 18 except that the taperTDE is not utilized, and instead the distal end is configured to besimilar to the distal end shown in the sleeve 400″ of FIG. 31. Thesurfaces ICS and OCS have generally corresponding shapes and need not bestraight or cylindrical, i.e., they can also be, e.g., tapered or havean other non-straight shapes. The device 100 ^(V) also includes a spring600 which functions to move the needle holder 30 distally when the outercircumferential surface OCS of the needle holder 30 is released fromfrictional engagement with the inner circumferential surface ICS of theproximal end of the inner sleeve 400 ^(V). Once a user moves the cap tothe closed position, the sleeve 400 ^(V) is caused to move axially inthe proximal direction which, in turn, causes outer circumferentialsurface OCS of the needle holder 30 no longer frictionally engage withthe inner circumferential surface ICS of the proximal end of the innersleeve 400 ^(V). The spring 600 is then free to move the needle holder30 within the sleeve 400 ^(V) in a distal direction which ensures thatthe needle holder 30 is fully and safely arranged within the device 100^(V). The device can then be safely handled and discarded.

The disengagement of the proximal end of the sleeve 400 ^(V) from theneedle holder 30 functions as follows. The sleeve 400 ^(V) is preventedfrom moving axially backwards within the body 200 ^(IV) by either acircumferential tapered shoulder (similar to shoulder TS' of FIG. 31) orby projections (similar to projections P of FIG. 11), and is biasedtowards this distal direction by the spring 600 which, in FIG. 37, isalmost fully compressed. The sleeve 400 ^(V) has a plurality of proximalslots PS which divide the proximal end of the sleeve 400 ^(V) into aplurality of spring fingers each having a portion of the surface ICS.The body 200 ^(IV) includes two oppositely arranged tapered projectionsOATP arranged therein which are each configured to engage (i.e., wedgeopen) with one of the proximal slots PS of the sleeve 400 ^(V) when thesleeve 400 ^(V) is moved in the proximal direction by the cap.Furthermore, when the sleeve 400 ^(V) is moved in the proximal directionby the closing of the cap, the tapered surfaces of the projections OATPare contacted the side surfaces of the spring fingers defined by theslots PS and causes the spring fingers formed by the proximal slots PSto expand radially thereby releasing the engagement between the surfaceICS of the sleeve 400 ^(V) and the surface OCS of the holder 30. As aresult, the proximal slots PS widen. This movement of the sleeve 400^(V) and disengagement of the surfaces ICS and OCS is caused to occurautomatically when the user moves the cap to the closed position, andmore specifically, when an annular surface or proximal end of capcontacts an annular surface or distal end of the sleeve 400 ^(V) andforces the sleeve 400 ^(V) to move axially in the proximal direction.

Thus, when the user moves the cap to the closed position (not shown),axial movement of the sleeve 400 ^(V) automatically causes the surfaceICS to separate from the surface OCS. Since the frictional engagementbetween the surface ICS and the surface OCS constitutes the onlyengagement or connection between the holder 30 and the sleeve 400 ^(V),the disengagement of these surfaces leaves the holder 30 free to moveaxially distally. Furthermore, because the spring 600 maintains abiasing force against the holder 30, when this engagement is released,the spring 600 will automatically expand axially and force the holder 30to move distally within the sleeve 400 ^(V). This, in turn, results inthe needle N being retracted into the sleeve 400 ^(V) (similar to theway shown in FIG. 39) and positions it safely within the body 200 ^(IV).The device 100 ^(V) is then rendered unusable, i.e., cannot be reused,and can be safely handled and disposed of without fear of the needlecausing injury to persons who handle the used device 100 ^(V).

As was the case with some previous embodiments, the sleeve 400 ^(V) andthe needle holder 30 constitute a sub-assembly. The proximal end of thesleeve 400 ^(V) forms a plurality of arc-shaped sections or fingersdivided by equally spaced slots PS. The slots PS can be a few as twooppositely arranged slots or as many as, e.g., 20 or more, with anywhole number between 2 and 20 being utilized. As such, these fingers arefree to deflect outwardly or to slightly elastically deformed outwardly.Furthermore, the spring fingers can include breakable and/or stretchableconnections (similar to connections BEC shown in FIG. 33) which aredesigned to break or stretch when the spring fingers are caused toradially expand beyond a certain point, as occurs when the slots PSengages with the tapered surfaces of the projections OATP. Theseintegrally formed members BEC also ensure that the fingers are pressedtightly against the holder 30, and more specifically, that the surfacesOSC and ICS remain in engagement until the slots PS engage with thetapered surfaces of the projections OATP which allows the fingers todeflect outwardly. In order to assemble this sub-assembly, one need onlyslide the holder 30 into the proximal end of the sleeve 400 ^(V). Theholder 30 is then prevented from moving axially relative to the sleeve400 ^(V) by virtue of engagement between the projections CPP (see FIG.16) and the corresponding shaped recess(s) or groove(s) in the surfaceICS.

FIG. 39 shows another non-limiting embodiment of a blood collectiondevice 100 ^(VI) according to the invention. The device 100 ^(VI)includes all of the features of the embodiment of FIGS. 27-38, exceptthat instead of two proximal slots PS, the sleeve 400 ^(VI) utilizesfour proximal slots PS, and the body 200 ^(V) utilizes four equallyangularly spaced projections OATP instead of just two oppositelyarranged projections. The device 100 ^(VI) otherwise functions in thesame way as that of FIGS. 37-38.

FIGS. 40 and 41 show another non-limiting embodiment of a bloodcollection device 100 ^(VII) according to the invention. The device 100″includes a generally cylindrical outer sleeve or outer body member 200^(V) which includes a proximal end 200 ^(V) a configured to allow anexternal needle N of a double-ended needle member or holder 30 to passtherethrough, and a distal end which can be closed off by a cap 500″. Aninner flange IF is arranged at the proximal end 200 ^(V) a. The needleholder 30 has an outer circumferential surface OCS which frictionallyengages with an inner circumferential surface ICS of a proximal end ofan inner sleeve 400 ^(VII). The sleeve 400 ^(VII) can have aconfiguration similar to that of FIG. 18 except that the taper TDE isnot utilized, and the proximal slots PS are made wider than the distalslots DS. The surfaces ICS and OCS have generally corresponding shapesand need not be straight or cylindrical, i.e., they can also be, e.g.,tapered or have an other non-straight shapes. The device 100 ^(VII) alsoincludes a spring 600 which functions to move the needle holder 30distally when the outer circumferential surface OCS of the needle holder30 is released from frictional engagement with the inner circumferentialsurface ICS of the proximal end of the inner sleeve 400 ^(VII). Once auser moves the cap 500″ to the closed position, the sleeve 400 ^(VII) iscaused to move axially in the proximal direction which, in turn, causesouter circumferential surface OCS of the needle holder 30 no longerfrictionally engage with the inner circumferential surface ICS of theproximal end of the inner sleeve 400 ^(VII). The spring 600 is then freeto move the needle holder 30 within the sleeve 400 ^(VII) in a distaldirection which ensures that the needle holder 30 is fully and safelyarranged within the device 100 ^(VII). The device can then be safelyhandled and discarded.

The disengagement of the proximal end of the sleeve 400 ^(VII) from theneedle holder 30 functions as follows. The sleeve 400 ^(VII) isprevented from moving axially backwards within the body 200 ^(V) by theoppositely arranged projections P1, and is biased towards this distaldirection by the spring 600 which, in FIG. 40, is almost fullycompressed. The sleeve 400 ^(VII) has a plurality of proximal slots PSwhich divide the proximal end of the sleeve 400 ^(VII) into a pluralityof spring fingers each having a portion of the surface ICS. The body 200^(V) includes two oppositely arranged circular projections P2 arrangedtherein which are each configured to engage (i.e., wedge open) with oneof the proximal slots PS of the sleeve 400 ^(VII) when the sleeve 400^(VII) is moved in the proximal direction by the cap 500″. Furthermore,when the sleeve 400 ^(VII) is moved in the proximal direction by theclosing of the cap 500″, the tapered surfaces of the proximal slot PSare contacted the circular surface of the projection P2 and this causesthe spring fingers formed by the proximal slots PS to expand radiallythereby releasing the engagement between the surface ICS of the sleeve400 ^(VII) and the surface OCS of the holder 30. As a result, theproximal slots PS widen. This movement of the sleeve 400 ^(VII) anddisengagement of the surfaces ICS and OCS is caused to occurautomatically when the user moves the cap 500″ to the closed position,and more specifically, when an annular surface or proximal end of cap500″ contacts an annular surface or distal end of the sleeve 400 ^(VII)and forces the sleeve 400 ^(VII) to move axially in the proximaldirection.

Thus, when the user moves the cap 500″ to the closed position (notshown), axial movement of the sleeve 400 ^(VII) automatically causes thesurface ICS to separate from the surface OCS. Since the frictionalengagement between the surface ICS and the surface OCS constitutes theonly engagement or connection between the holder 30 and the sleeve 400^(VII), the disengagement of these surfaces leaves the holder 30 free tomove axially distally. Furthermore, because the spring 600 maintains abiasing force against the holder 30, when this engagement is released,the spring 600 will automatically expand axially and force the holder 30to move distally within the sleeve 400 ^(VII). This, in turn, results inthe needle N being retracted into the sleeve 400 ^(VII) and positions itsafely within the body 200 ^(V). The device 100 ^(VII) is then renderedunusable, i.e., cannot be reused, and can be safely handled and disposedof without fear of the needle causing injury to persons who handle theused device 100 ^(VII).

As was the case with some previous embodiments, the sleeve 400 ^(VII)and the needle holder 30 constitute a sub-assembly. The proximal end ofthe sleeve 400 ^(VII) forms a plurality of arc-shaped sections orfingers divided by equally spaced slots PS. The slots PS can be a few astwo oppositely arranged slots or as many as, e.g., 20 or more, with anywhole number between 2 and 20 being utilized. As such, these fingers arefree to deflect outwardly or to slightly elastically deformed outwardly.Furthermore, the spring fingers can include breakable and/or stretchableconnections (similar to connections BEC shown in FIG. 33) which aredesigned to break or stretch when the spring fingers are caused toradially expand beyond a certain point, as occurs when the slots PSengages with the circular projections P2. These integrally formedmembers BEC also ensure that the fingers are pressed tightly against theholder 30, and more specifically, that the surfaces OSC and ICS remainin engagement until the tapered surfaces of the slots PS engage with thecircular projections P2 which allows the fingers to deflect outwardly.In order to assemble this sub-assembly, one need only slide the holder30 into the proximal end of the sleeve 400 ^(VII). The holder 30 is thenprevented from moving axially relative to the sleeve 400 ^(VII) byvirtue of engagement between the projections CPP (see FIG. 16) and thecorresponding shaped recess(s) or groove(s) in the surface ICS.

FIG. 42 shows another non-limiting embodiment of a blood collectiondevice 100 ^(VIII) according to the invention. The device 100 ^(VIII)includes all of the features of the embodiment of FIGS. 40-41, exceptthat the projections P1 and the distal slots DS are not utilized, andinstead tapered stop shoulder projections TS″ are utilized to preventdistal movement of the sleeve 400 ^(VIII). The device 100 ^(VIII)otherwise functions in the same way as that of FIGS. 40-41.

The devices described above can also utilize one or more featuresdisclosed in the prior art documents expressly incorporated by referenceherein. Furthermore, one or more of the various parts of the device canpreferably be made as one-piece structures by e.g., injection molding,when doing so reduces costs of manufacture. Non-limiting materials formost of the parts include synthetic resins such as those approved forsyringes, blood collection devices, or other medical devices.Furthermore, the invention also contemplates that any or all disclosedfeatures of one embodiment may be used on other disclosed embodiments,to the extent such modifications function for their intended purpose.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof the present invention. While the present invention has been describedwith reference to an exemplary embodiment, it is understood that thewords which have been used herein are words of description andillustration, rather than words of limitation. Changes may be made,within the purview of the appended claims, as presently stated and asamended, without departing from the scope and spirit of the presentinvention in its aspects. Although the present invention has beendescribed herein with reference to particular means, materials andembodiments, the present invention is not intended to be limited to theparticulars disclosed herein; rather, the present invention extends toall functionally equivalent structures, methods and uses, such as arewithin the scope of the appended claims.

What is claimed:
 1. A retractable medical device comprising: a bodyhaving an open back end and a front end; a movable member arrangedwithin the body, the movable member having a back end and a front end; aneedle holding member movable to a retracted position within the movablemember when the movable member experiences at least one of: the frontend of the movable member is caused to expand generally radially; theback end of the movable member is caused to contract generally radially;the front end of the movable member is caused to expand generallyradially when the back end of the movable member is caused to contractgenerally radially; axial movement caused by a cap closing off the backend of the body which engages a tapered surface of the back end of themovable member.
 2. The device of claim 1, wherein the body and themovable members are at least one of generally cylindrical and generallytubular.
 3. The device of claim 1, wherein the movable member is sizedand configured to at least partially receive therein one of a fluidcollection tube and an evacuated blood collection receptacle.
 4. Thedevice of claim 1, wherein an outer peripheral surface of the needleholding member frictionally engages with an inner surface of the frontend of the movable member.
 5. The device of claim 1, wherein an outerperipheral surface of the needle holding member comprises at least oneprojection which engages with at least one recess arranged on an innersurface of the front end of the movable member.
 6. The device of claim1, wherein an outer peripheral surface of the needle holding membercomprises at least one recess which engages with at least one projectionarranged on an inner surface of the front end of the movable member. 7.The device of claim 1, wherein the body comprises a device arrangedwithin the body for limiting axial movement of the movable member withinthe body.
 8. The device of claim 1, further comprising a cap structureand arranged to close off a back end of the body.
 9. The device of claim1, further comprising a cap having a portion which contacts the back endof the movable member.
 10. The device of claim 1, further comprising acap having tapered surfaces which contact tapered surfaces of the backend of the movable member.
 11. The device of claim 1, further comprisinga cap structured and arranged to lock to the back end of the body. 12.The device of claim 1, further comprising a cap structured and arrangedto cause the needle holding member to move to the retracted positionwhen the cap is locked to the body.
 13. The device of claim 1, furthercomprising a cap structured and arranged to cause the needle holdingmember to move to the retracted position when the cap closes off theback end of the body.
 14. The device of claim 1, further comprising acap structured and arranged to cause the needle holding member to moveto the retracted position when the cap engages with a back end of themovable member.
 15. The device of claim 1, wherein the movable membercomprises an internal surface which limits retraction movement of theneedle holding member.
 16. The device of claim 1, wherein the movablemember comprises an internal annular surface which limits retractionmovement of the needle holding member.
 17. The device of claim 1,wherein the needle holder is structured and arranged to one of: supporta double-ended needle; and retain a removable double-ended needle. 18.The device of claim 1, further comprising a cap having an outer rimlarger than an opening in the back of the body and an inner rimcomprising at least one protrusion structured and arranged to engagewith the back end of the movable member.
 19. A retractable medicaldevice comprising: a tubular body having an open back end and a frontend; a movable sleeve arranged within the body, the movable sleevehaving a back end and a front end; the movable sleeve being sized andconfigured to at least partially receive therein one of a fluidcollection tube and an evacuated blood collection receptacle; a needleholding member comprising a centrally disposed opening for receiving adouble-ended needle and being axially retained in an area of the frontend of the movable sleeve; and a cap structured and arranged toclose-off the back end of the tubular body, wherein, when the cap ispositioned to close-off the back end of the tubular body, at least oneof: the movable sleeve experiences axial movement which participates incausing the front end of the movable sleeve to expand generallyradially; the back end of the movable sleeve experiences radialcontraction which causes the front end of the movable sleeve to expandgenerally radially; and the back end of the movable sleeve experiencesradial contraction which causes portions of the front end of the movablesleeve to pivot open.
 20. A method of taking a fluid sample using thedevice of claim 1, the method comprising: inserting a receptacle intothe device; removing the receptacle from the device; and placing the caponto the back end of the tubular body to thereby cause the needleholding member to move to the retracted position.